The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.
Neko Health AB raised $260 million in its series B funding round to expand the reach of its artificial intelligence (AI)-driven full body scanning technology to meet growing demand. The fund raise comes amid an increasing shift in behaviors towards more preventative measures in health care in a bid to remove the risk of developing chronic diseases.
Newco Linkgevity Ltd. has won backing from the KQ Labs accelerator program at the Francis Crick Institute in London, enabling it to take forward the lead program, an anti-necrotic drug for treating acute kidney injury, and to further develop its AI-driven system for identifying aging-related therapeutic targets.
A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.
Accunea Ltd. is looking to reduce the number of kidneys that are discarded with its bioanalysis technology Renosure, which can detect critical changes in organ function in real-time, both before and after transplantation. The company is looking to raise £1.6 million (US$2 million) to develop the device which could transform the lives of people requiring a kidney transplant.
Icelandic genomics company Arctic Therapeutics has closed a €26.5 million (US$27.6 million) series A, enabling it to assess if its lead drug AT-001, designed to treat a rare inherited amyloid disease, also could be used to treat more common forms of dementia, including Alzheimer’s disease. The program is currently in a phase IIb/III European trial in cystatin C amyloid angiopathy, an ultra-rare disease found only in Iceland that is caused by the L68Q mutation in the cystatin C gene.
Device makers know all too well the hazards of liability where their products are concerned, but those liabilities may soon balloon dramatically in the EU. Two pieces of EU legislation are in development, including the AI Liability Directive, which may have the effect of forcing the defendant in a liability case to prove that its product was not the cause of the alleged harm.
The European Union has implemented legislation governing artificial intelligence (AI) with more on tap, but the U.S. has to date lagged in that area. However, the House of Representatives has assembled a bipartisan task force for AI, one of several developments suggesting that 2025 will be an even more AI-focused year than 2024.
Owlstone Medical Ltd. recently secured $27 million in the first close of its series E financing round for clinical trials and product commercialization based on its Breath Biopsy platform technology. The fundraise was led by Ventura Capital, joined by Aviva Ventures, Horizons Ventures and other existing investors.
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
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